Catheter anchoring system

ABSTRACT

A catheter anchoring system is provided to securely anchor to a patient&#39;s skin a catheter and fluid supply tube interconnection. The anchoring system comprises a retainer configured to receive a catheter adaptor in a variety of positions. The adaptor interconnects the catheter and the fluid supply tube. In one embodiment the adaptor includes a lure-lock fitting to lock onto a hub on the proximal end of the catheter. The anchoring system additionally includes a flexible, adhesive anchor pad which supports a tube clip, as well as the retainer. The retainer includes a channel that is configured to receive the adaptor in a snap-fit manner. The retainer also includes a plurality of lateral slots. Each slot is sized to receive and to capture a radically extending member (e.g., an annular collar) of the adaptor to prevent the adaptor from sliding within the channel.

This application is a continuation of application Ser. No. 08/223,948,filed Apr. 6, 1994, now U.S. Pat. No. 5,578,013 which is acontinuation-in-part of copending application Ser. No. 08/121,942, filedSep. 15, 1993 now U.S. Pat. No. 5,456,671, which is acontinuation-in-part of copending application Ser. No. 08/034,340, filedMar. 19, 1993, now U.S. Pat. No. 5,354,282 which is acontinuation-in-part of copending application Ser. No. 07/695,549, filedMay 3, 1991 now U.S. Pat. No. 5,314,411, which is a continuation-in-partof application Ser. No. 07/518,964, filed May 4, 1990, now U.S. Pat. No.5,192,273, issued Mar. 9, 1993, which is a continuation-in-part ofapplication Ser. No. 07/384,326, filed Jul. 24, 1989, now abandoned.

BACKGROUND OF THE INVENTION

1. Field of the Invention

The present invention relates in general to a percutaneouscatheterization system, and, in particular, to a catheter anchoringsystem which securely interconnects an indwelling catheter with a tubingand securely anchors such interconnection to a patient's skin.

2. Description of Related Art

Medical treatment of patients commonly involves the use ofpercutaneously inserted catheters to direct fluids directly into thebloodstream, a specific organ or an internal location of the patient, orto monitor vital functions of the patient. For instance,intra-arteriosus catheters are commonly used to direct fluids and/ormedication directly into the bloodstream of the patient. Epiduralcatheters are commonly used to direct anesthesia into an epidural spaceto anesthetize a specific location of the patient. Intervascularcatheters are commonly used to monitor arterial blood pressure.

The fluid (e.g., parenteral liquid, medication or anesthesia) typicallydrains from a container positioned above the patient. The fluid flowsthrough tubing and into an indwelling catheter. The catheter and fluidtubing are commonly removably attached by a conventional luer-typeconnector, such as the type described in U.S. Pat. No. 4,224,937.

In common practice, a health care provider, such as, for example, anurse or doctor (for ease of description, as used herein the term"nurse" will refer to health care providers generally and will not berestrictive in meaning), uses adhesive or surgical tape to maintain thecatheter in place on the skin of the patient. The connection between thetubing and the catheter is likewise maintained by use of tape.

The nurse may also form a safety loop in the tubing so that any tensionapplied to the tubing does not directly pass to the catheter cannula,but rather is absorbed by the slack of the safety loop. The nursetypically loosely tapes the loop to the skin of the patient.

This entire taping procedure takes several minutes of the valuable timeof the health care provider. Furthermore, nurses commonly remove theirgloves when taping because most nurse find such taping proceduresdifficult and cumbersome when wearing gloves.

The catheterization process often requires frequent disconnectionbetween the catheter and the fluid supply tube. For instance,intravenous catheterization is frequently maintained for several days,depending upon the condition of the patient. The catheter tubing isgenerally replaced every 24 to 48 hours in order to maintain thesterility of the fluid and the free-flow of the fluid through thetubing. A nurse must thus frequently change the tubing and retape theconnection. Moreover, the tape, which secures the catheter to the skinof the patient, often covers the cannula insertion point. The nurse mustremove the tape to inspect the insertion point for inflammation orinfection, and must then repeat the above-described taping procedure.

A great deal of valuable time is thus used in applying significantamounts of surgical tape to indwelling catheters. The frequentapplication and removal of surgical tape also commonly results in theexcoriation of the skin of the patient in the area of the insertion.

A number of catheterization systems have recently been developed whichimprove the stabilization of the catheter system and obviate the needfor frequent application and removal of surgical tape. One such systemis disclosed by U.S. Pat. No. 5,192,273 issued to the present Applicant,which is hereby incorporated by reference.

The '273 patent discloses an adaptor which interconnects the catheterwith a fluid supply tubing. The adaptor snaps into a base attached tothe patient's skin by an adhesive pad. Specifically, a nurse presses theadaptor between upstanding legs of the base. Detents on the adaptor legsslide into corresponding annular grooves in the adaptor body to hold theadaptor to the base.

Although the base holds the adaptor securely in place, a nurse may havedifficulty positioning and aligning the annular grooves of the adaptorwith the detents on the base. Exigent circumstances may furtherexacerbate the difficulties associated with properly positioning theadaptor onto the base. Some nurses and other health care providers mayalso have trouble determining how to engage the catheter adaptor withthe base.

SUMMARY OF THE INVENTION

The catheter anchoring system of the present invention provides anadaptor retainer which is not position or technique sensitive. That is,the nurse simply locates the catheter adaptor generally above theretainer, and presses the adaptor into the retainer. Engagement requiresonly coarse alignment of the adaptor with the retainer.

In accordance with a preferred embodiment of the present invention, theretainer comprises a pair of opposing longitudinal walls. Each walldefines a series of slots which are laterally aligned with the opposingslots of the opposite side wall. Each slot is sized such that a portionof the catheter adaptor (e.g., a support arm or an annular collar orflange) inserts into at least one slot. So positioned, the adaptor isprevented from moving in a direction generally parallel to alongitudinal direction of the retainer.

The central channel is generally U-shaped and is formed by the arcuateshape of the walls. The channel axis lies, in a vertical plane,generally parallel to the retainer longitudinal axis. The channel isinterposed between the opposing longitudinal walls and has a truncatedcircular cross-sectional shape. The central channel, in cross-section,extends through an arc, which is greater than 180° about the channelaxis, such that with the adaptor body positioned within the channel, thelongitudinal walls prevent the adaptor from moving either in a lateraldirection or in a transverse direction (which are normal to thelongitudinal axis of the retainer).

The channel axis and its bottom surface is preferably positioned obliqueto the horizontal at an angle substantially equal to an incident angleof the indwelling catheter. This incident angle preferably rangesbetween 0° and 30°.

In accordance with a further aspect of the present invention, a catheteranchoring system is provided to securely retain a catheter adaptor(which interconnects a catheter and a tubing) on the skin of thepatient. The anchoring system comprises a base having a rail extendingin a longitudinal direction, and a retainer configured to receive andretain the catheter adaptor. The retainer comprises a groove configuredto receive the rail in a manner enabling the retainer to slide over thebase. The anchoring system further comprises an interlocking elementwhich prevents the retainer from sliding over the base with the retainerholding the catheter adaptor.

The interlocking element preferably comprises a plurality of teeth and apawl. The pawl engages the teeth with the retainer holding the adaptor.The pawl desirably extends from a flexible finger which the adaptordeflects when positioned within the retainer.

In accordance with a further aspect of the present invention, a catheteranchoring system comprises a catheter adaptor, a retainer and a base padwhich adheres to the skin of a patient and supports the retainer. Thecatheter adaptor comprises a tubular body connected to a radiallyextending support arm. The support arm in turn connects to a clip whichpivots relative to the tubular body.

The retainer comprises a pair of opposing longitudinal walls. Each walldefines a series of slots. Each slot is sized such that a portion of thesupport arm of the catheter adaptor extends through the slot. The slotprevents the support arm from moving in a direction generally parallelto a longitudinal direction of the retainer.

The retainer further comprises a central channel which extends throughthe retainer about an axis which is generally parallel to thelongitudinal axis. The channel is interposed between the opposinglongitudinal walls and has a truncated circular cross-sectional shape.The central channel, in cross-section, is sized to encompass the tubularbody through an angle greater than about 180°.

The anchoring system may additionally comprise a tube clip configured toreceive a portion of the tube. The anchoring system may also comprise anS-clip having a plurality of retainers to secure a microbore tubingconnected to the tube by the adaptor.

In a preferred embodiment, the anchoring system additionally comprises abase having a rail that extends in the longitudinal direction. Theretainer includes a corresponding shaped groove configured to receivethe rail. The retainer slides over the base with the rail positionedwithin the groove.

The anchoring system may also comprise an interlocking element whichprevents the retainer from sliding over the base with the retainerholding the adaptor. The interlocking element desirably comprises aseries of teeth and a pawl.

In accordance with a preferred method of anchoring a catheter to apatient, a base is positioned proximate to an indwelling catheter. Aretainer is slid over the base to locate the retainer in a desiredposition relative to the indwelling catheter. An adaptor is insertedinto the retainer to prevent the adaptor from moving relative to theretainer, and the retainer and base are interlocked to prevent theadaptor from moving relative to the indwelling catheter.

In a preferred embodiment, the adaptor deflects a cantilevered finger asit is inserted into the retainer. The deflection of the finger in turncauses a pawl to engage a series of teeth. The interengagement betweenthe teeth and pawl prevent the retainer from sliding over the base. Withthe adaptor removed from the retainer, the retainer freely slides overthe base.

The method desirably further includes the steps of attaching thecatheter adaptor to the indwelling catheter. The distal end of theadaptor is inserted into the proximal end of the catheter hub which isthen engaged by a clip slidably mounted on the adaptor. The clip is slidproximally on the adaptor to grasp the catheter hub. With the clip sopositioned, the clip is locked in place to secure the engagement withthe catheter hub.

An additional aspect of the present invention provides a catheteranchoring system for securing an indwelling catheter within a body lumenof a patient and for securely interconnecting the indwelling catheterwith a tube. The catheter anchoring system comprises a catheter adapterhaving a generally tubular body defined between distal and proximalends. The distal end is configured to engage the catheter proximal endand the proximal end is configured to couple to a distal end of thesupply tube. The catheter adapter additionally comprises a radiallyextending member which projects from an exterior surface of the tubularbody in a radial direction.

A retainer of the catheter anchoring system comprises a longitudinalchannel configured to receive the tubular body of the adapter in a snapfit manner. The retainer additionally comprises a plurality of lateralslots which are sized to receive and to capture the radially extendingmember of the adapter with the adapter positioned within the channel.The retainer prevents the adapter from sliding in a longitudinaldirection when one of the slots receives the radially extending member.

In a preferred embodiment, the radially extending member comprises asupport arm which connects a clip to the tubular body. In an alternativepreferred embodiment, the radially extending member comprises an annularcollar which circumscribes the tubular body.

An additional aspect of the present invention provides a catheteranchoring system comprising an anchor pad. The anchor pad has a laminatestructure formed by a cellulose foam layer an adhesive layer. The anchorpad preferably has a roughened or porous upper surface to facilitateattachment of the retainer or tube clip by an adhesive. A woven fiber(e.g., paper may be attached to the foam to form the upper layer.Alternatively, the top surface of the foam layer may be corona treatedto form the upper surface.

The anchor pad generally has a trapezoidal shape defined by paralleldistal and proximal edges. The distal edge has a length longer than theproximal edge. A notch extends into the anchor pad from the distal edgeand has a sufficient size such that a health care provider can visuallyinspect the catheter cannula with an anchor pad position about thecatheter.

The anchor pad may preferably include indicia (e.g., arrow, figure,words, etc.) which identify the desired direction of orientation of theanchor pad with respect to the indwelling catheter. The anchor padpreferably has rounded corners and the longitudinal side edges haveconcave configurations. The anchor pad desirably supports a retainerwhich receives a catheter adapter. The retainer is preferably alignedwith the notch of the anchor pad.

In accordance with a preferred method of anchoring an indwellingcatheter/tube interconnection to a patient, an adapter is providedhaving a generally tubular body with a radially extending member. Ananchor pad is also provided with an adhesive back. The anchor padsupports a retainer configured to receive the adapter and has a seriesof lateral slots. The anchor pad is attached to the patient's skinproximate to an indwelling catheter. The radially extending member ofthe adapter is positioned above the series of slots. The retainer isdeflected so as to open the channel to a size sufficient to receive theadapter, and the adapter is inserted into the channel. The radiallyextending member is inserted into one of the slots. The retainer is thenpermitted to spring back to an undeflected position such that thetubular body is captured within the retainer.

Another method of the present invention comprises the steps of providingan anchor pad which supports the retainer. The retainer is configured toreceive a catheter adapter. The anchor pad has a trapezoidal shapeformed by a longer distal edge and a shorter proximal edge. The anchorpad further includes an adhesive backing. The anchor pad is positionedover the patient's skin such that the shorter proximal side is generallyadjacent to the indwelling catheter. The anchor pad is adhered to thepatient's skin.

An additional aspect of the invention involves an anchoring system for acatheter. The anchoring system includes an adaptor which has a generallytubular body with a distal end. The distal end of the adaptor isconfigured to engage a proximal end of the catheter. The distal end alsoincludes a luer-lock connector which is adapted to engage acorresponding luer-lock connector of the catheter proximal end. Theadaptor additionally includes a radially extending member which projectsfrom an exterior surface of the adaptor body in a radial direction andat a point which is distanced from the luer-lock connector of theadaptor distal end.

The anchoring system also includes a retainer. The retainer includes achannel that is configured to receive the body of the adaptor. Theretainer also includes a plurality of longitudinal slots. Each slot issized to receive and to capture the radially extending member of theadaptor with the adaptor positioned within the channel of the retainer.In this manner, the adaptor is prevented from sliding within theretainer channel.

BRIEF DESCRIPTION OF THE DRAWINGS

These and other features of the invention will now be described withreference to the drawings of preferred embodiments which are intended toillustrate and not to limit the invention, and in which:

FIG. 1 is a perspective view of a catheter anchoring system inaccordance with a preferred embodiment of the present invention, mountedon the back of a patient's hand;

FIG. 2 is a top plan view of the catheter anchoring system of FIG. 1;

FIG. 3 is a top plan view of a retainer of the catheter anchoring systemof FIG. 2;

FIG. 4a is a front elevational view of the retainer of FIG. 3;

FIG. 4b is a rear elevational view of the retainer of FIG. 3;

FIG. 5 is a side elevational view of the retainer of FIG. 3;

FIG. 6 is a top plan view of a catheter anchoring system in accordancewith another preferred embodiment of the present invention;

FIG. 7a is a front elevational view of a retainer and rail assembly ofthe catheter anchoring system of FIG. 6;

FIG. 7b is a side elevational view of the retainer and rail assembly ofFIG. 6;

FIG. 8 is a cross-sectional view of the retainer and rail assembly takenalong line 8--8 of FIG. 7a;

FIG. 9 is a top plan view of a catheter anchoring system in accordancewith an additional preferred embodiment of the present invention;

FIG. 10 is a side elevational view of an S-clip of the catheteranchoring system of FIG. 9 taken along line 10--10;

FIG. 11 is a top perspective view of a catheter anchoring system inaccordance with an additional preferred embodiment of the presentinvention;

FIG. 12 is a top plan view of the catheter anchoring system of FIG. 11illustrating an adaptor held by a retainer;

FIG. 13a is a side elevational view of the retainer of FIG. 12;

FIG. 13b is a top plan view of the retainer of FIG. 12; and

FIG. 14 is a partially sectioned perspective view of an alternativeembodiment of a catheter adaptor which may be used with the anchoringsystem of FIG. 11.

DETAIL DESCRIPTION OF PREFERRED EMBODIMENTS

FIG. 1 illustrates in perspective view a catheter anchoring system 10 inaccordance with the present invention. The anchoring system 10 securelyconnects a tube 12 (e.g., a fluid supply tube) to an indwelling catheter14 and maintains the catheter 14 in the desired indwelling position. Theanchoring system 10 is designed for rapid attachment to the catheter 14and to the patient, without requiring precise alignment or positioningof the components of the anchoring system 10.

Moreover, sturdy anchoring of the catheterization system is achievedwithout the use of surgical tape. For most catheterization, theanchoring system is attached to the patient only once. Although thefluid supply tubing 12 may be replaced every 24 to 48 hours forintravenous catheterization, the components of the anchoring system 10attached to the patient remains in place. Thus, surgical tape need notbe applied and removed from the patient's skin on multiple occasions.

The catheter anchoring system 10 principally comprises a flexible pad 16having an adhesive bottom side 18 which attaches to the skin of apatient when used. The pad 16 supports a retainer 20. The retainer 20 isconfigured to receive and secure in place a catheter adaptor 22 whichinterconnects the hub 30 of an indwelling catheter 14 and the fluidsupply tube 12 connected to a fluid supply container (not shown). Thecontainer maintains the fluid to be dispensed to the patient which isfed either by gravity or by pressure. A clamp (not shown) may be used toregulate the fluid flow through the tubing 12. The pad 16 may also issupport a tubing clip 24 which is used to retain a portion of tubing 12.

Although FIG. 1 illustrates the catheter anchoring system located on theback of a patient's hand (illustrated in phantom lines), it iscontemplated that the present invention may be used for catheterizationin other locations on the patient's body. For instance, the anchoringsystem may be used on the medial side of the wrist in connection with aradial artery. The anchoring system 10 may also be used for epiduralcatheterization, as discussed in detail below, and thus located on theanterior or posterior of the patient's torso.

FIG. 1 illustrates a longitudinal axis, a transverse axis and a lateralaxis in relation to the catheter anchoring system 10 to facilitate thefollowing description. Additionally, as used herein, "the longitudinaldirection" refers to a direction substantially parallel to thelongitudinal axis. "The lateral direction" and "the transversedirection" are in reference to the lateral axis and transverse axis,respectively. Also, "proximal" and "distal" are in reference to theproximity of the fluid supply container attached to the tube 12 (seeFIG. 1). The individual components of the catheter anchoring system 10will now be described in detail.

Catheter Adaptor

FIG. 1 illustrates the catheter adaptor 22 interconnected with acatheter 14. FIG. 2 illustrates the catheter adaptor 22 disconnectedfrom catheter 14. Although these figures illustrate the adaptor 22 asthe type disclosed in U.S. Pat. No. 5,193,273, it is contemplated thatother types of adaptors can be used as well with the present catheteranchoring system 10. For instance, the catheter adaptor 22 could be alure-type adaptor, such as the type illustrated by FIG. 11 and describedbelow, or a luer-lock type catheter adaptor 22, such as the typeillustrated by FIG. 14 and described below. It is contemplated thatthose skilled in the art could readily select the type of catheteradaptor 22 to be used with the present catheter anchoring system 10depending on the particular application (e.g., venous, arterial,epidural, peripheral, etc.) of the anchoring system 10.

As best seen in FIG. 2, the adaptor 22 comprises a tubular body 25defined between a distal end 26 and a proximal end 28. The proximal end28 is adapted to receive a distal end of the tube 12. In an exemplaryembodiment, at least a portion the fluid supply tube is permanentlyattached to the body proximal end 28. As shown in FIG. 2, the proximalend of the tubing may then include a standard lure-type connector 29 toconnect into a fluid supply line 12.

The distal end 26 is configured to engage the proximal hub 30 of thecatheter 14 (see FIG. 1) or any lure-type connector. Although FIG. 2illustrates the distal end of the adaptor 22 as having a frusto-conicalshape configured to engage a standard luer-type catheter hub 30, it iscontemplated that the distal end 26 could be configured as well toengage other types of catheter connectors, such as, for example, aToughy-Bourst adaptor.

A support arm 32 extends outwardly from the tubular body 25 incantilever fashion. The support arm 32 supports, on a radially outer endof the arm 32, a clip support element (not shown) that extends generallyparallel to and is spaced from a longitudinal axis of the tubular body25.

FIG. 2 further illustrates a clip 34 of the catheter adaptor. The clip34 attaches to and slides over the clip support element in thelongitudinal direction. The clip 34 includes a distal latch 36 which hasa generally forked shape to engage a outer surface of the catheter hub30 distal of a hub collar 38 (see FIG. 1) to securely attach the adaptor22 to the catheter hub 30.

Interengaging structure (not shown) between the clip support element andthe clip 34 permits the clip 34 to slide in the proximal direction, butprevents the clip 34 from sliding in the distal direction. Theinterengaging element desirably comprises a series of ratchet teeth (notshown) disposed up on upper surface of the clip support element and apawl (not shown) connected to the clip 34. The pawl extends from theclip 34 in a cantilever fashion and engages the ratchet teeth to preventdistal movement of the clip, as discussed in detail in U.S. Pat. No.5,193,273, which has been incorporated by reference.

The tubular body 25, the support arm 32 and the clip support element arepreferably integrally formed of molded plastic, such as, for example, aclear polycarbonate, so as to be generally stiff, but somewhat flexible.The support arm 32 desirably has enough elasticity to bend. Depressingthe proximal end of the clip 34 towards the tubular body 25 moves thelatch 36 of the clip 34 away from the tubular body 25. In this manner,the clip 34 pivots about the tubular body 25.

With reference again to FIG. 2, the clip support element desirablycomprises a protuberance 40 positioned on an inner surface 42 of theclip support element, proximate to the proximal end of the clip 34. Theprotuberance is spaced from the support arm by a distance L. Theprotuberance 40 prevents the clip 34 from pivoting when secured by theretainer 20, as discussed below in detail. The protuberance 40 alsolimits the degree of deflection of the support arm 32 to reduce fatigue,as fully explained in U.S. Pat. No. 5,193,273, which has beenincorporated by reference.

Retainer for Catheter Adaptor

FIGS. 3 through 5 illustrate the retainer 20. The retainer 20 has agenerally parallelepiped shape defining a central channel 44 interposedbetween a pair of opposing longitudinal walls 46. The central channel 44extends through the retainer 20 along an axis which is generallyparallel to the longitudinal axis of the retainer.

As best seen in FIG. 4, the central channel 44 has a generally circularcross-sectional shape which is truncated at a upper end to form agenerally U-shaped channel having an upper opening 47. The centralchannel 44 has a diameter sized to receive the tubular body 25 of thecatheter adaptor 22. In a preferred embodiment, the diameter of thecentral channel 44 generally matches that of the tubular body 25 or isslightly larger.

In cross-section, the central channel 44 extends through an arc greaterthan 180° about the channel axis such that the transverse length of theopening 47 is less than the diameter of the central channel 44. In anexemplary embodiment, the central channel 44 extends through an arc ofabout 200° about the channel axis.

FIG. 5 illustrates the channel axis which is desirably skewed relativeto a base surface 48 of the retainer 20. An incident angle θ formedbetween the base surface 48 and the channel axis is less than 45°. Theincident angle θ desirably ranges between 0° and 30°. In an exemplaryembodiment for intravenous use, the angle θ preferably equalsapproximately 7°. In another exemplary embodiment for arterial use, theincident angle θ preferably equals about 22°. In a further exemplaryembodiment, for peripherally inserted central catheters (PICC), theincident angle θ preferably equals 0°.

The longitudinal walls 46 are substantially identical. Each wall 46 hasa thickness measured in the lateral direction less than the length ofthe support arm 32. The wall 46 is thus interposed between the tubularbody 25 and the clip 34 when the tubular body 25 is inserted into thecentral channel 44. The length of each wall 46, measured in thelongitudinal direction, is preferably coextensive with the length of theretainer 20.

Each wall 46 comprises a uniform series of slots 50. The seriescomprises at least two (2) slots 50, and not more than twenty (20) slots50. More preferably, the series comprises less than seven (7) slots 50.In an exemplary embodiment, as illustrated in the figures of theapplication, the series comprises four (4) slots 50.

Each slot 50 is sized to receive the support arm 32 of the catheteradaptor 22 to prevent longitudinal displacement of the adaptor 22, asdiscussed in detail below. Each slot 50 desirably has a rectangularshape. As seen in FIG. 3, the slots 50 extend from an exterior surface52 through the wall 44, and open into the central channel 44. The widthof each slot 50 (measured longitudinally) is desirably slightly greaterthan the width of the support arm 32, measured in the longitudinaldirection to receive the support arm 32, as discussed below.

As illustrated by FIG. 5, each slot 50 has a height as measured in thetransverse direction between an upper edge 54 of the longitudinal wall46 and the bottom 56 of the central channel 44. The height of the slot50 desirably equals approximately the width of the support arm 32 suchthat the support arm 32 does not protrude from the retainer 20 in thetransverse direction.

The spacing S between the slots 50, on center, desirably equals abouthalf the distance L (see FIG. 2) between the support arm 32 and theprotuberance 40 of the catheter adaptor 22.

As FIG. 3 illustrates, a distance X between the most distal slot 50 andthe distal end of the retainer 20 is less than the longitudinal distanceY (see FIG. 2) between the support arm 32 and the latch 36 positioned inits most proximal position. This spacing enables the support arm 32 torest in the most distal slot 50 with the latch 36 retaining a catheterhub 30 distal of the retainer distal end.

FIG. 5 illustrates the upper edge 50 of the longitudinal wall 46 whichcomprises a series of chamfers 58, each of which slopes into a slot 50.That is, the portion of upper edge 50 of the longitudinal wall 46 whichsurrounds a slot 50 includes a pair of chamfers 58, with one chamfer 58located on either side of the slot 50. The chamfers 58 slope downwardtoward the slot 50 to facilitate the insertion of the support arm 32 ofthe catheter adaptor 22 into the slot 50, as discussed below.

As shown by FIGS. 3 and 5, each longitudinal wall 46 further comprises arelief 60 disposed on the proximal end of the retainer 20. The relief 60is sized to receive the protuberance 40 of the adaptor 22. The depth ofthe relief 60 measured in the lateral direction desirably is slightlygreater than the height of the protuberance 40 (i.e., the distance bywhich the protuberance protrudes from the inner surface 42).

The relief 60 is spaced in the longitudinal direction from the mostproximal slot 50 by a distance approximately equal to the spacing Sbetween the slots 50. Thus, the protuberance 40 rests in the relief 60with the support arm 32 positioned in either of the two most proximalslots 50, as discussed in detail below.

FIGS. 3 and 4 illustrate a key-way groove 62 of the retainer 20. Thekey-way groove 62 facilitates the removal of the catheter adaptor 22from the retainer 20, as discussed below in detail. The key-way groove62 lies at the proximal end of the retainer 20. The key-way groove 62extends into the retainer 20, and toward the retainer base surface 48from the bottom surface 56 of the central channel 44. The key-way groove62 has a transverse width less than the diameter of the central channel44, and more preferably has a width approximately equal to two-thirdsthe diameter of the central channel 44. The longitudinal length of thekey-way groove 62 desirably equals approximately the longitudinal lengthof the recesses 60 in the longitudinal walls 46.

The retainer 20 is made of relatively stiff plastic material (e.g.,polycarbonate), but is somewhat flexible such that the adaptor 22 forcesthe upper edges 54 of the longitudinal walls 46 outwardly when a nursepresses the adaptor 24 into the central channel 44 of the retainer 20.When the adaptor 22 sits in the central channel 44, the upper edges 54of the walls 46 snap inwardly to their original position to securelyhold the adaptor 22 within the retainer 20.

An adhesive attaches the retainer 20 to base pad 16. Alternatively, theretainer 20 may be attached to the base pad 16 by like means (e.g.,embedding or otherwise weaving the retainer 20 into the base pad 16) aswell.

Base Pad

As illustrated by FIG. 1, the flexible base pad 16 comprises a laminatestructure comprising an upper paper or other woven or non-woven clothlayer 64, an inner cellulose foam layer 66, and the bottom adhesivelayer 18. Alternative, the flexible base pad 16 may comprise an adhesivebottom layer and an upper cellulose foam layer. An upper surface of thefoam layer is roughened by corona treating the foam with a low electriccharge, as known in the art. The roughened or porous upper surface ofthe base pad 16 improves cyano-acrylate (or other types of adhesive)adhesion when attaching the retainer 20 to the pad 16.

A removable paper or plastic backing (not shown) desirably covers thebottom adhesive layer 18 before use. The backing preferably resiststearing and is divided into a plurality of pieces to ease attachment ofthe pad 16 to the patient's skin, as explained below. Desirably, thebacking is split along the center line of the flexible base pad 16 inorder to expose only half of the adhesive bottom surface 18 at one time.The backing also advantageously extends beyond at least one edge of thebase pad 16 to ease removal of the backing from the adhesive layer 18.

As seen in FIG. 2, one or more tabs 67 may be attached to a portion ofthe backing which extends beyond the flexible base pad 16. In anexemplary embodiment, the tabs 67 have the same laminate structure asthe flexible base pad 16. The tabs 67 also can be formed by the paperbacking extending beyond the edge of the base pad 16. The tab 67 mayalso include indicia 69 in the form of dots, words, figures or the liketo indicate the placement of fingers when removing the backing from thebase pad 16.

A nurse grips the tab 67, preferably at the location of the indicia 69,and peels the backing off one half of the bottom adhesive layer 18. Thenurse then places the bottom layer 18 against the patient's skin toadhere the base pad 16 to the patient. Light pressure over the upperlayer 64 assures good adhesion between the base pad 16 and the patient'sskin. The base pad 16, due to its flexibility, conforms to the contoursof the topical surface to which the base pad 16 adheres. The nurse thenrepeats this procedure for the other half of the pad 16. Alternatively,the nurse may completely remove the backing from the pad 16 beforeattaching the pad 16 to the patient's skin.

The base pad 16 desirably comprises a notch 68 positioned distal of thelocation of the retainer 20 on the pad 16 and adjacent to the point ofinsertion of the catheter cannula. The notch 68 is sized to permitvisual inspection of the catheterized site.

As seen in FIG. 2, the base pad 16 desirably may comprise indicia 70 inthe form of an arrow which indicates the proper orientation of the basepad 16 in reference to catheterized site. Although the figuresillustrate the indicia in the form of an arrow, it is contemplated thatother forms of indicia, such as, for example, words or other graphics,could be used as well. In proper use, as illustrated in FIG. 1, theindicia 70 should point in the proximal direction, towards theindwelling catheter 14, or otherwise indicate the proper locate of thepad 16 in reference to the indwelling catheter 14.

In an exemplary embodiment, the laminate structure of the base pad ispreferably formed by rolling a paper tape, such as a micro-porous rayontape, available commercially as MICRO-PORE tape from 3M (Item No. 1530),over a medical grade polyvinyl chloride foam tape, such as thatavailable commercially from 3M (Item No. 9777L). The foam tapepreferably includes the bottom liner or backing. The base pad 16 and thetabs 67 are then stamped out of the laminated sheet of foam and paper.The backing between the tabs and the base pad, however, is desirably notsevered such that the tabs 67 remain attached to the backing coveringthe adhesive section 18 of the base pad 16. The backing is then cut intotwo pieces along the center line of the pad 16 and between the tabs 67.

Tube Clip

FIGS. 1 and 2 illustrate the tube clip 24. The clip 24 secures the fluidsupply tube 12 to form a safety loop, as known in the art.

The tube clip has a plate-like base 72 adhered to or embedded in thebase pad 16. The tube clip 24 may be located on the base pad 16 oneither side of the retainer 20 to accommodate left hand or right handmounting. As illustrated in FIG. 6, the anchoring system 10 may furtherinclude a second tube clip 24 located on the other side of the retainer20 from the first tube clip 24.

The clip 24 defines a channel 74 having a generally circularcross-sectional configuration truncated to form an upper orifice 76. Thediameter of the channel 74 is desirably slightly less than that of thefluid supply tube 12 so as to ensure a secure interconnection. Thechannel 74 receives a portion of the fluid supply tube 12 through theorifice 76 upon application of gentle pressure or by pulling the tubing12 across and through the orifice 76 of the tube clip 24, as explainedbelow. The clip 24 surrounds a substantial portion of the tubing 12 withthe tubing 12 positioned within the channel 74.

As seen in FIG. 2, the upper edge of the channel includes tapered ends77 at the proximal and distal ends of the clip 24. Each tapered end 77forms a smooth transition between the side edge of the channel 74 andthe upper edge, and tapers in lateral width from the side edge towardthe center of the tube clip 24. The tapered ends 77 help guide the fluidsupply tube 12 into the channel 74 when a nurse pulls the tube acrossthe clip 24. Thus, the nurse does not have to pinch the tube 12 toinsert it into the clip 24. Also, the nurse's gloves do not get stuck inthe clip 24 when inserting the tube 12, as is typically the case wherethe nurse is required to pinch the tube 12 to insert it into the clip24.

Slide Clamp

As illustrated in FIGS. 1 and 2, the catheter anchoring system 10desirably additionally includes a slide clamp 78 to regulating fluidflow through the tubing, as known in the art. The clamp 78, at one end,includes an aperture 80 which receives the fluid supply tube 12, and, atthe opposite end, includes a tab 82. The clamp 78 has a generally forkedshape formed by a pair of prongs 84 which defines the aperture 80. Thetube 12 snaps between the prongs 84 and into the aperture 80, which hasa diameter slightly larger that the fluid supply tube 12.

The prongs 84 converge together in the direction towards the tab 82 toform a tapering slot 86 which opens into the aperture 80. The prongs 84pinch the tube 12 closed with the tube 12 positioned in the slot 86 soas to block fluid flow therethrough. The clamp 78, however, slides overthe tube 12 with the tube 12 positioned through the aperture 80.

The tab 82 desirably has a rectangular shape which generally correspondsthe to shape of the key-way groove 62 of the retainer 20. The tab 82preferably has a thickness greater than that of the distal end ofkey-way groove 62, measured in the transverse direction, so as to prythe adaptor 22 from the retainer 20. As explained in detail below, thetab 82 may be used to remove the catheter adaptor 22 from the retainer20.

Retainer Location Adjustment Mechanism

FIGS. 6 through 8 illustrate a catheter anchoring system 10a inaccordance with another preferred embodiment of the present invention.Where appropriate, like numbers with an "a" suffix have been used toindicate like parts of the two embodiments for ease of understanding.

The catheter anchoring system 10a is substantially identical to theabove-described anchoring system 10, with the addition of a retainerlocation adjustment mechanism 90.

As best seen in FIG. 8, the location adjustment mechanism 90 comprises abase 92 and interlocking mechanism 94 which interconnects the base 92and the retainer 20a. The retainer 20a slides over the base 92 and theinterlocking mechanism 94 secures the retainer 20a to the base 92 atvarious longitudinal positions. The adjustment mechanism thus allows forprecise positioning of the retainer 20 relative to the catheter 14 afterthe pad 16 is attached to the patient's skin.

The base 92 has a generally parallelepiped shape and comprises a rail96. FIG. 7a best illustrates that the rail 96 desirably has a"dove-tail" configuration in cross section. That is, the rail 96 has across-sectional shape with a flat upper edge 98 and a pair of opposingside edges 100, each edge 100 being angled inward from the upper edge 98toward the middle of the rail 96. The rail 96 extends along thelongitudinal length of the base 92 from the distal end 102 of the base92 to a point just short of the base proximal end 104. The base 92includes a pair of stops 106 at the proximal end 104 which close off theproximal end of the rail 96.

An adhesive attaches the base 92 to base pad 16a. Alternatively, thebase 92 may be attached to the base pad 16a by like means (e.g.,embedding or otherwise weaving the base 92 into the base pad 16a) aswell.

The retainer 20a, configured in accordance with the above-description,additionally comprises a groove 108 having a cross-sectional shapecorresponding to that of the rail 96. The retainer groove 108 receivesthe base rail 96 in a manner permitting the retainer 20a to slide overthe base 92, but preventing the retainer 20a from moving in thetransverse direction away from the base 92. The base stops 106 alsolimit the retainer's longitudinal travel in a proximal direction.

The interlocking mechanism 94 comprises a plurality of teeth 110disposed on an upper surface 112 of the base 92, and a pawl 114connected to the retainer 20a. The teeth 110 desirably have generallyrectangular cross-sectional shapes, and lie in seriatim along thelongitudinal axis of the base 92. The upper edge of each tooth 110includes a chamfer 112 to facilitate the engagement of the pawl 114 witha hollow 116 formed between adjacent teeth 110, as discussed below. Thelongitudinal length of each tooth 110 desirably extends generally normalto the longitudinal axis of the base 92.

The pawl 114 has a shape configured to insert into and engage with thehollow 116 defined between the teeth 110. The pawl 114 preferably has awidth, measured in the longitudinal direction, slightly less than thatof the hollow 116.

The retainer 20a comprises an aperture 118 extending between theretainer base surface 48a and the channel bottom surface 56a. A flexiblefinger 120 extends from the retainer 20a in a cantilever fashion andinto the retainer aperture 118. The flexible finger 120 supports thepawl 114 at its distal end. Although FIG. 8 illustrates the finger 120as extending in the distal direction, it is contemplated that the finger120 can alternatively extend in the proximal direction as well.

The flexible finger 120 preferably comprises a protuberance 122 whichextends upwardly beyond the channel bottom surface 56a and into thecentral channel 44a with the finger 120 in an undeflected state. Thecantilever nature of the finger 120 enables the finger 120 to deflectdownward so that the protuberance 122 lies below the retainer bottomsurface 56a. With the finger 120 so deflected, the pawl 114 engages theseries of teeth 110. That is, the pawl 114 inserts into a hollow 116defined between the teeth 110. The interengagement between pawl 114 andthe teeth 110 prevents the retainer 20a from sliding over the base 92.

S-Clip

FIGS. 9 and 10 illustrate a catheter anchoring system 10b in accordancewith a further embodiment of the present invention. Where appropriate,like numbers with an "b" suffix have been used to indicate like parts ofthe embodiments for ease of understanding.

The catheter anchoring system 10b is substantially identical to theanchoring system 10 first described above, with the addition of anS-clip 124 to retain a microbore or small bore tubing 126. The microboretubing is commonly used, for example, with epidural catheterizationprocedures, as discussed in detail below.

The S-clip 124 comprises a generally U-shaped channel 128 defined by apair of arcuate, upstanding walls 130 extending from a base plate 132.As best seen in FIG. 10, the S-clip 124 further comprises a plurality ofretainers 134, each retainer 134 having a spherical head 136 support bya cylindrical stem 138. The stems 138 extend from the base plate 132.The retainer stems 138 are positioned from one another and from theupstanding walls 130 by a distance slightly greater than the diameter ofthe microbore tubing 126. The retainers 134 are also positioned suchthat the spherical heads 136 of the retainers 134 are positioned fromone another and from the upstanding walls 130 by a distance slightlyless than the microbore tubing 126. As best seen in FIG. 10, theretainer heads 136 prevent the microbore tubing 126 from disengagingfrom the S-clip 124 in the transverse direction once the microboretubing 126 is snaked between the retainers 134 and the upstanding walls130.

An adhesive attaches the base plate 132 of the S-clip 124 to base pad16b. Alternatively, the base plate 132 may be attached to the base pad16b by like means (e.g., embedding or otherwise weaving the base plate132 into the base pad 16b) as well.

The components of the anchoring system 10, save the base pad 16 (i.e.,the retainer 20, tube clip 24, adaptor 22, slide clamp 78, base 92 andS-clip 124), may be constructed in any of a variety of ways which willbe well known to one of skill in the art. For instance, each individualcomponent may be integrally molded such as by injection molding or bythermoplasty. The components preferably comprise a durably, flexiblematerial, and more preferably comprise a generally inert, non-toxicmaterial. In a preferred embodiment, the components are molded ofplastic, such as, for example, polycarbonate, polyvinylchloride,polypropylene, polyurethane, tetrafluoroethylene (e.g., TEFLON®),polytetrafluoroethylene (a.k.a., PTEF), acetal resin (e.g., DELRIN®),chlorotrifluoroethylene (e.g., KEL-F®), nylon or like polymers.

Method of Use

The following discussion of the method of use will be with reference toFIGS. 1 and 2, and initially will be in the context of intravenouscatheterization. As the following discussion will illustrate, however,it is understood that the anchoring system 10 can be used in othercatheterization procedures as well. The discussion of the method of useis intended to augment the above description of the invention, and,thus, should be read together.

A nurse typically begins the catheterization process by positioning thecatheter 14 at a desired location above a vein. The nurse introduces aneedle or other stylus through a cannula portion of the catheter 14 andinto the skin of the patient at a desired angle of incident. Forintravenous use, the catheter 14 commonly has an incident angle ofapproximately 7°. The nurse then inserts the cannula of the catheter 14into the patient and withdraws the needle or stylus. The catheter hub 30remains exposed above the skin.

The nurse inserts the distal end of the adaptor 26 into the catheter hub30. The clip 34 has been slidably mounted in a most distal position sothat it does not interfere with the insertion of the adaptor distal end26 into the catheter hub 30.

The nurse then slides the clip 34 in a proximal direction to engage thecatheter hub 30. In this manually selected position, the clip 34securely attaches the adaptor 22 to the catheter 14. The rachet teeth ofthe adaptor 22 cooperate with the pawl to resist distal movement of theclip 34 and to hold the clip 34 in the manually selected position.

The nurse removes the paper backing which initially covers the adhesivebottom surface 18 of the base pad 16, and attaches the pad 16 to thepatient's skin proximate to the indwelling catheter 14. Specifically,the nurse grips the backing tab 67 proximate to the retainer 20. Theindicia 69 on the tab 67 indicates the locate at which the nurse shouldgrip the tab 67. The nurse then pulls on the tab 67 and peels thebacking off one half of the bottom adhesive layer 18. The nursepositions the slot 68 of the pad 16 around the catheter cannula 14 withthe instructing indicia 70 (e.g., indicating arrow) pointing in thedirection of the catheter 14. The nurse then places the bottom layer 18against the patient's skin to adhere the base pad 16 to the patient.Light pressure over the upper layer 64 assures good adhesion between thebase pad 16 and the patient's skin. The base pad 16, due to itsflexibility, conforms to the contours of the topical surface to whichthe base pad 16 adheres.

The nurse then repeats this procedure for the other half of the pad 16.Alternatively, the nurse may completely remove the backing from the pad16 before attaching the pad 16 to the patient's skin.

The nurse orients the adaptor 22 with the clip 34 positioned to the sideof the tubular body 25 (i.e., with the support arm 32 extending in thelateral direction) and locates the adaptor support arm 32 above theseries of retainer slots 50 with the latch 36 positioned distal of theretainer distal end.

The nurse then snaps the adaptor 22 into the retainer 20 locatedproximal of the pad notch 68. In doing so, the adaptor 22 is pressedbetween the longitudinal walls 46 of the retainer 20 with the supportarm 32 extending in a lateral direction. As the nurse presses theadaptor 22 into the retainer 20, the chamfered edges 58 around the slots50 of the longitudinal wall 46 guide the support arm 32 into one of theslots 50.

As mentioned above, the opening 47 of the channel 46 has a smaller widthmeasured in the lateral direction than the diameter of the tubular body25. The lateral walls 46 thus deflect outwardly in a lateral direction.Once the tubular body 25 of the adaptor 22 rests within the centralchannel 44 of the retainer 20, the lateral walls 46 spring back to snapthe adaptor 22 in place. The walls 46 of the retainer 20 thus preventunintentional transverse and lateral movement of the adaptor 22.

In this position, the protuberance 40 of the adaptor 22 either restseither in a slot 50 or in the relief 60, proximal of the slot 50 throughwhich the support arm 32 passes. The protuberance 40 engages a portionof the longitudinal wall 46, which forms either the relief 60 or theslot 50, to prevent the clip 34 from pivoting relative to the tubularbody 25. The protuberance 40 thus ensures that the latch 36 maintainsengagement with the catheter hub 30.

The slot 50 through which the support arm 32 passes prevents the adaptor22 from sliding in the longitudinal direction. That is, the slot 50prevents longitudinal displacement of the adaptor 22 when secured withinthe central channel 44.

The ergonomic design of the retainer 20 provides for a variety ofpositions of the adaptor 22 in the retainer 20 so that the retainer 22is not technique or position sensitive. That is, a nurse can simplypress the adaptor 22 into the retainer 20, irrespective of the side onwhich the support arm 32 is located, and irrespective of the position ofthe support arm 32 relative to a particular slot 50. So long as thesupport arm 32 is positioned above the series of slots 50, the chamferededges 58 of the wall 46 will guide the support arm 32 into a slot 50.The protuberance 40 of the adaptor 22 also fits within an adjacent slot50 or the relief 60.

With the support arm 32 extending through a slot 50 of the retainer 20,the adaptor 22 lies in a "low profile" position. That is, the supportarm 32 of the adaptor 22 extends in the lateral direction to reduce theoverall height of the anchoring system 10, as measured in the transversedirection. This position of the adaptor 22 reduces the risk of thesystem 10 interfering with surrounding action. The retainer 20, however,allows the adaptor 22 to rotate either to a position in which thesupport arm 32 extends in the transverse direction, or to a position180° for the original position to locate the adaptor clip 34 on theopposite side of the retainer 20.

Once in the low profile position, the adaptor 22 will normally remain inthis position until the adaptor 22 and its associated tubing 12 areremoved and replaced by another.

As FIG. 1 illustrates, the nurse may also form a safety loop in thefluid supply tubing 12, as known in the art, and secure the safety loopto the patient by inserting a portion of the tubing 12 into the tubeclip 24. The safety loop absorbs any tension applied to the fluid supplytube to prevent the adaptor 22 and/or catheter 14 from being pulled.

A nurse may use the slide clamp 78 to remove the adaptor body 25 fromthe retainer 20. The nurse inserts the tab 82 of the slide clamp 78 intothe key-way groove 62 on the proximal end of the retainer 20. Becausethe tab 82 has a larger width than the depth of the key-way groove 62,measured in the transverse direction, the tab 62 pries the tubular body25 from the central channel 44 as the nurse inserts the tab 82 into thekey-way groove 62 in the distal direction. The nurse may further use theslide clamp 78 to leverage the proximal end of the tubular body 25 outthe upper opening 47 of the retainer 20. Having displaced the proximalend of the adaptor 22 from the retainer 20, the nurse may easily removethe adaptor distal end from of the retainer 20. Alternatively, the nursemay also remove the tubular body 25 by lifting up on the tubing 12 whileholding down the pad 16 or the retainer 20 with the other hand.

FIGS. 6 through 8 illustrate the catheter anchoring system 10aparticularly suited for arterial catheterization. Because of thecriticality of the incident angle (i.e., the angle at which the catheter14a projects into the patient) at which the catheter 14a must bemaintained, it is advantageous to precisely position the retainer 20a sothat the retainer 20a holds the catheter 14a at the desired incidentangle. The desired range of incident angle commonly is about 5°-30° forarterial catheterization. The incident angle preferably ranges betweenabout 15° and about 25°, and more preferably equals about 22°.

A nurse inserts the catheter cannula 14a into an artery in a similarmanner to that described above in connection with intravenouscatheterization. The nurse subsequently connects the adaptor 22a to theindwelling catheter 14a as previously described. The nurse also attachesthe flexible pad 16a to the patient in a like manner to that describedabove. If desired, the nurse can remove one of the wings 140 of the pad16a before attaching the pad 16a to the patient, by tearing the pad 16aalong the perforation line 142.

The nurse orients the adaptor 22a with the clip 34a positioned to theside of the tubular body 25a (i.e., with the support arm 32a extendingin the lateral direction) and locates the adaptor support arm 32a abovethe series of retainer slots 50a with the latch 36a positioned distal ofthe retainer distal end. If the nurse positions pad 16a too close to ortoo far from the indwelling catheter 14a, the nurse can slide theretainer 20a in the desired direction to locate the retainer slots 50abeneath the adaptor support arm 32a.

The nurse then snaps the adaptor 22a into the retainer 20a locatedproximal of the pad notch 68a. In doing so, the chamfered edges 58aaround the slots 50a of the longitudinal wall 46a guide the support arm32a into one of the slots 50a. The retainer 20a automatically slideslongitudinally to precisely position a corresponding slot 50a beneaththe support arm 32a.The adaptor 22a thus snaps into the retainer 20awithout causing the catheter 14a to move substantially.

The tubular body 25a contacts the protuberance 122 of the finger 120 andcauses the finger 120 to deflect downward as the adaptor tubular body25a snaps into the central channel 44a. In turn, the pawl 114 engagesthe series of teeth 110 which prevents longitudinal movement of theretainer 20a while holding the adaptor 20a. If the nurse removes theadaptor 22a--preferably by using the slide clamp tab 82a--the finger 120springs back to its undeflected state and the retainer 20a freely slidesover the rail 96. The pawl 114 normally does not engage the series ofteeth 110.

The ability to precisely position the retainer 20a beneath the catheteradaptor 22a connected to the catheter 14a, enables the nurse to hold thecatheter 14a in a stable position and ensures that the retainer 20a willhold the adaptor 22a, and thus the catheter 14a, at the precise incidentangle. Without the ability to adjust the longitudinal position of theretainer 20a, the nurse may perform a series of position iterationsbefore properly locating base pad 16a, and thus the retainer 20a,relative to the indwelling catheter 14a.

For epidural catheterization, an anesthesiologist, for example, insertsthe distal end of microbore tubing 126 into the epidural space. Theproximal end of the microbore tubing 126 conventionally includes aToughy-Bourst adaptor 144 or other adaptor device to couple with thefluid supply tube 12b transporting the anesthesia. It is imperative thatthe connection between the microbore tubing 126 and the fluid supplytubing 144 remain intact, and that the distal end of the microboretubing 126 remains in place. For if the epidural space is exposed toair-borne microbes, meningitis may develop. Thus, a secureinterconnection between the microbore tubing 126 and the fluid supply12b should exist, and the microbore tubing 126 should be isolated fromany tension placed on either the fluid supply tube 12b, as well as theadaptor 22b.

FIGS. 9 and 10 illustrate the catheter anchoring system 10b particularlysuited for epidural catheterization. A doctor uses the present anchoringsystem 10b in a manner similar to that described above in connectionwith intravenous catheterization, with the exceptions that doctorconnects the adaptor 22b to microbore tubing 126 and adheres the basepad 16b to the patient's torso.

The doctor subsequently snakes the microbore tubing 126 through theS-clip 124 by first pressing the tubing 126 between a retainer 134 andthe wall 130, and then wrapping the tubing 126 between the first andsecond retainers 134. Light pressure forces the tube 126 between theretainers 134. The doctor then wraps the tube 126 back between thesecond retainer 134 and the second wall 130, and presses the tube 126therebetween. The S-clip 124 secures the microbore tube 126 in place andisolates the microbore tube 126 from tension placed on the adaptor 22band/or the fluid supply tube 12b with the microbore tube 126 insertedaccordingly.

Additional Embodiments

As mentioned above, it is contemplated that other types of adaptors inaddition to the one disclosed above can be used as well with the presentcatheter anchoring system. FIGS. 11 and 12 illustrate a catheteranchoring system 10c in accordance with a further embodiment of thepresent invention which includes a different catheter adaptor style.Where appropriate, like numbers with a "c" suffix have been used toindicate like parts of the embodiments for ease of understanding.

Like the catheter anchoring systems described above, the presentcatheter anchoring system 10c principally comprises a flexible anchorpad 16c having an adhesive bottom side 18c, which attaches to the skinof the patient. The pad 16c supports a retainer 20c. The retainer 20c isconfigured to receive and secure in place a catheter adaptor 22c whichconnects to an indwelling catheter 14c. The pad 16a may also support atube clip 24c which is used to retain a portion of the tubing 12c.

FIG. 11 illustrates the adaptor 22c as comprising a generally tubularbody 25c defined between a distal end 26c and a proximal end 28c. Theproximal end 28c is adapted to receive a distal end of the tube 12c. Inan exemplary embodiment, at least a portion of the fluid supply tube 12cis permanently attached to the body proximal end 28c.

The distal end 26c is configured to engage a proximal end of theindwelling catheter 14c (not shown). Although FIGS. 11 and 12 illustratethe distal end 26c of the adaptor 22c as having a frusto-conical shapeconfigured to engage a standard lure-type catheter hub 30c (not shown),it is contemplated that the distal end 26c could be configured as wellto engage other types of connectors.

FIG. 14 illustrates an alternative configuration of the distal end 26dof the catheter adaptor 22d. Again, for consistency, like numbers with a"d" suffix have been used to indicate like parts of the catheter adaptorof FIG. 11 and the catheter adaptor of FIG. 14.

The catheter adaptor 22d includes a standard luer-lock type fitting 220attached to the body 25d of the catheter adaptor 22d so as tocircumscribe the distal end 26d of the catheter adaptor 22d. Theluer-lock fitting 220 preferably is attached in a manner which permitsthe fitting 220 to be rotated about the catheter adaptor body 25d. It iscontemplated, however, that the distal end of the adaptor could comprisea female luer-lock type connector (i.e., a hub including nubs or threadson its external surface) as well if required by a particularapplication.

In the illustrated embodiment, the fitting 220 has a generally tubularshape with a closed proximal end 222. The closed end 222 includes anaperture 224 of a sufficient size to receive a portion of the adaptorbody 25d, as described below. The fitting 220 includes conventionalinternal threads 226 in order to engage corresponding threads of aconventional female luer-lock fitting (not shown).

The adaptor body 25d desirably includes an annular groove 228 whichreceives a portion of the closed end 222 of the fitting 220 tointerconnect the fitting 220 and the adaptor body 25d. Thisinterconnection also permits the fitting 220 to be rotated about theadaptor body 25d.

To assemble the catheter adaptor 22d, the conical shaped distal end 26dof the body 25d is inserted into the aperture 224 of fitting closed end222. The body 25d is then forced into the fitting 220 to slightlydeflect the closed end 222 until the closed end 222 snaps into theannular groove 228 of the body 25d. In this position, the body 25dcaptures a portion of the fitting 220 to couple these elements together.

With reference to FIG. 11, the adaptor 22c includes at least one annularcollar 200 interposed between the proximal and distal ends 28c, 26c ofthe tubular body 25c. The adaptor 22d of FIG. 14 also includes a likeannular collar 200d. It is contemplated that the collar 200 of theadaptor 22c of FIG. 11 and the collar 200d of the adaptor 22d of FIG. 14will be substantially identical, and, thus, the description herein willbe understood as applying equally to both embodiments.

The annular collar 200 flares radially outwardly and circumscribes thetubular body 25c. The annular collar 200 has a thickness measured in alongitudinal direction which is slightly less than a width of a slot 50cin a retainer wall 46c so that the collar 200 fits within the slot 50cof a retainer wall 46c, as discussed in detail below.

The adaptor 22c is preferably formed of a durable, biocompatible plasticmaterial. The adaptor 22c more preferably is formed of clear plastic soa nurse can see bubbles or backflow through the adaptor 22c. In anexemplary embodiment, the adaptor is formed of polycarbonate byinjection molded; however, those skilled in the art will readilyappreciate that the adaptor can be formed by other construction methodsknown in the art.

FIGS. 11 and 12 also illustrate the retainer 20c which is substantiallyidentical to the retainer 20 described above. The retainer 20c comprisesa central channel 44c interposed between a pair of opposing longitudinalwalls 46c. The central channel 44c extends through the retainer 20calong an axis which is generally parallel to a longitudinal axis of theretainer 20c.

The central channel axis 44c has a generally circular cross-sectionalshape which is truncated at an upper end to form an opening 47c. Thecentral body 44c has a diameter sized to receive the tubular body 25c ofthe catheter adaptor 22c. In a preferred embodiment, the diameter of thecentral channel 44c generally matches that of the tubular body 25c.

In cross section, the central channel 44c extends through an arc greaterthan 180° about the channel axis such that the lateral length of theopening 47c is less than the diameter of the central channel 44c. In anexemplary embodiment, the cross-sectional shape of the central channel44c extends through an arc of about 200° about the channel axis.

As best seen in FIG. 13a, the channel axis is desirably skewed relativeto a base surface 48c of the retainer 20c. An incident angle θ formedbetween the base surface 48c and the channel axis is less than 45°. Theincident angle θ desirably ranges between 5° and 30°. In an exemplaryembodiment for intravenous use, the angle θ preferably approximatelyequals 7°.

The longitudinal walls 46c are substantially identical. Each wall 46chas a thickness measured in the lateral direction less than the lengthof the support arm 32 of the adaptor 22, as it is desirable for thepresent retainer 20c to accept both the above-described adaptor 22 whichcomprises a support arm 32 connected to a clip 34, as well as thepresent adaptor 22c which comprises an annular collar 200. Preferably,the thickness of the wall 46c measured in the lateral direction isgreater than the distance measured radially by which the collar 200extends beyond the exterior surface of the tubular body 25c (i.e., aradial height). The length of each wall 46c, as measured in thelongitudinal direction, is preferably coextensive with the length of theretainer 20c.

Each wall 46c comprises a uniform series of slot 50c. The seriescomprises at least two (2) slots 50c and not more than twenty (20) slots50c. More preferably, the series comprises less than seven (7) slots50c. In an exemplary embodiment, as illustrated in the figures, theseries comprises four (4) slots 50c.

As discussed above, each slot 50c is sized to receive the collar 200 ofthe adaptor 22c, as well as the support arm 32 of the catheter adaptor22, to prevent longitudinal displacement of the respective adaptor 22,22c. Each slot 50c desirably has a rectangular shape. As seen in FIG.12, the slots 50c extend from an exterior surface 52c, through the wall46c, and open into the central channel 44c. The width of the slot 50c,as measured in the longitudinal direction, is desirably slightly greaterthan the width of the support arm 32 and the width of the collar 200.

As illustrated by FIG. 13a, each slot 50c extends in the transversedirection from an upper edge 54c of the longitudinal wall 46c to a pointbelow the bottom 56c of the central channel 44c. The height of the slot50c, as measured in the transverse direction, is thus greater than thedistance between the upper edge 54c and the channel bottom 56c of theretainer 20c. As seen in FIG. 13b, the retainer 20c further includes aseries of lateral grooves 202 which extend between opposing slots 50cand extend into the retainer 20c from the channel bottom surface 56c.The opposing slots 50c and groove 202 thus form a lateral channel whichextends through the retainer 20c in the lateral direction and cuts intothe retainer 20c from the upper edge 54c to a point below the channelbottom surface 56c. The groove 202 desirably is sized to receive aportion of the collar 200 such that with the tubular body 25c positionedwithin the central channel 44c, the collar 200 extends between opposingslots 50c and into the groove 202. Thus, the groove 202 has a depth,measured between the lower surface 56c of the central channel 44c andthe bottom of the groove in transverse direction, which is greater thanthe radial height of the annular collar 200.

FIG. 13b illustrates that the spacing S between the slots 50c, oncenter, desirably equals about half the distal L (see FIG. 2) betweenthe support arm 32 and the protuberance 40 of the catheter adaptor 22.The position of the slots in relation to the proximal and distal ends26c, 28c of the retainer 20c is desirably configured in accordance withthe spacing and positioning discussed above in connection with theabove-described retainer 22, such that the present retainer 22c can beused with the above-described adaptor 22, including a clip 34.

FIGS. 11 and 13a illustrate the upper edge of each longitudinal wall 46cwhich comprises a series of chamfers 58c formed and positioned asdisclosed above in connection with the retainer 20. As discussed above,the chamfers 58c slope downwardly towards the slot 50c to facilitate theinsertion of either the support arm 32 of the above-described catheteradaptor 22 or the annular collar 200 of the present catheter adaptor 22cinto the slot 50c.

As FIGS. 11-13b illustrate, each longitudinal wall 46c may furthercomprise a relief 60c disposed on the proximal end of the retainer 20c.The configuration and position of the relief 60c desirably is inaccordance with the above description of the retainer 20. FIG. 11further illustrates that the retainer 20c may additionally comprise akey-way groove 62c to facilitate removal of the catheter adaptor 22cfrom the retainer 20c, as discussed above. The key-way groove 62cdesirably is also positioned and configured in accordance with the abovedisclosure in connection with the retainer 20.

The retainer 20c is made of relatively stiff plastic material, but issomewhat flexible such that the adaptor 22c forces the upper edges 54cof the longitudinal walls 46c outwardly when a nurse presses the adaptor22c into the central channel 44c of the retainer 20c. The retainer 20cis desirably formed of polycarbonate by injection molding. When theadaptor 22c sits within the central channel 44c, the upper edges 54c ofthe walls 46c snap inwardly to their original position to securely holdthe adaptor 22c within the retainer 20c.

An adhesive preferably attaches the retainer 20c to the anchor pad 16c.Alternatively, the retainer 20c may be attached to the anchor pad 16c bylike means as well, e.g., embedding or otherwise weaving the retainerinto the anchor pad 16c.

FIG. 11 illustrates the anchor pad 16c as comprising a flexible,laminate structure comprising an upper paper or other woven or non-wovencloth layer 64c and a bottom adhesive layer 18c, with an inner cellulosefoam layer 66c interposed therebetween. Alternatively, the flexible basepad 16 may comprise an adhesive bottom layer 18 and an upper cellulosefoam layer. An upper surface of the foam layer is roughened by coronatreating with a low electric charge, as known in the art. The foam layer66c forms a cushion between the patient's skin and the rigid, plasticretainer 20c and tube clamp 24c. The adhesive layer 18c may comprise acoating of diaphoretic or nondiaphoretic material, depending upon thepatient's skin condition. A medical grade foam tape with a diaphoreticor a nondiaphoretic adhesive is available commercially from NDMManufacturers.

The removable paper or plastic backing (not shown) desirably covers thebottom adhesive layer 18 before use. As discussed above and illustratedin FIG. 12, the backing is preferably divided into a plurality of pieceand includes tabs 67c to ease removal of the backing from the pad 16.The tabs 67c may include indicia 69c (e.g., dots, text, arrows, etc.) toindicate the location at which to grip the corresponding tab 67c whenpeeling the removable backing off the pad 16c.

As best seen in FIG. 12, the anchor pad 16 desirably has a generallytrapezoidal shape with rounded corners. A distal edge 206 of the anchorpad 16c desirably has a width, as measured in the lateral direction,wider than that of a proximal edge 204. The longer distal edge 206provides a longer adhesive surface over a rough contact surface, suchas, for example, over knuckles, vertebrae, or the like. The generallytrapezoidal shape, however, minimizes the overall size of the anchor pad16c attached to the patient. The trapezoidal shape also provides thesame surface area as a square pad with a appearance of a smaller pad.The longitudinal sides 208 of the anchor pad 16c preferably taper fromthe proximal edge 206 to the distal edge 204, and more desirably haveconcave shapes.

The anchor pad includes a notch 68c positioned along the proximal edge204 of the anchor pad 16c and adjacent to the point of insertion of thecatheter cannula. Preferably, the notch 68c is symmetrically positionedabout the channel axis 44c of the retainer 20c attached to the anchorpad 16c. The notch 68c is sized to permit visual inspection of thecatheterized site and is large enough to allow for variable placement ofthe pad 16c with respect to the insertion site. That is, the notch 68cis large enough that a nurse is not required to precisely position thepad on the patient's skin with respect to the indwelling catheter 14c(not shown).

As seen in FIGS. 11 and 12, the anchor pad 16c desirably may compriseindicia 70c sometimes in the form of an arrow which indicates the properorientation of the anchor pad 16 in reference to the catheterized site.When properly used, the indicia 70c points toward the indwellingcatheter 14c (not shown).

The anchor pad 16c preferably supports a clip 24c which secures thefluid supply tube 12c to the anchor pad 16c. As seen in FIG. 12, thefluid supply tube 12c is preferably looped back around in a proximaldirection and inserted into the clip 24c to form a safety loop, as knownin the art. The tube clip 24c is desirably configured in accordance withthe above description. The clip 24c may be made in a variety of sizes toaccommodate various calibers of fluid flow tubing 12c.

In use, a nurse typically uses the catheter anchoring system 10c inconnection with an indwelling catheter 14c (not shown). The catheter 14cis inserted into a body lumen, such as a vein, in accordance with theabove description. The nurse then inserts the distal end 26c of theadaptor 22c into a catheter hub 30c (not shown) to connect the adaptor22c to the catheter 14c. The nurse may then secure the adapter 22c tothe catheter 14c by means of the ratchet clip, or the luer-lock fitting.

The nurse removes the paper backing which initially covers the adhesivebottom surface 18c of the anchor pad 16c, as described above, andattaches the anchor pad 16c to the patient's skin proximate to theindwelling catheter 14c. The nurse specifically positions the notch 68cof the pad 16c around the catheter cannula 14c with the indicating arrow70c pointing in the direction of the catheter 14c. The nurse generallyaligns the proximal edge 204 of the anchor pad 16c with the insertionsite.

The nurse positions the adaptor 22c above the series of retainer slots50c, and snaps the adaptor 22c into the retainer 20c. In doing so, theadaptor 22c is pressed between the longitudinal walls 46c of theretainer 20c with the annular collar 200 extending into opposing slots50c and into the corresponding groove 202 of the retainer 20c. As thenurse presses the adaptor into the retainer 20c, the chamfered edges 58caround the slots 50c of the longitudinal walls 46c guide the annularcollar 200 into the slots 50c. The retainer 20c secures the adaptor 20cas described above.

With the annular collar 200 positioned in the opposing slots 50c theadaptor 22c is prevented from sliding in a longitudinal direction.

Like the above-described embodiments of the retainer, the ergonomicdesign of the retainer 20c provides for various positions of the adaptor22c in the retainer 20c so that the retainer 22c is not technique- orposition-sensitive. That is, a nurse can simply press the adaptor 22cinto the retainer 20c, irrespective of the position of the annularcollar 20 relative to a particular slot 50c of the retainer 20c. So longas the annular collar 200 is positioned above the series of slots 50c,the chamfered edges 58c of the wall 46c will guide the annular collar200 into the slot 50c.

The present embodiment of the retainer 20c, as mentioned above, may alsobe used with the above-described adaptor 22 having the clip 34. A nurseuses the present retainer with the above-described adaptor 22 in thesame manner as described above in connection with the above-describedretainer 20.

If the catheter hub 30 (see FIG. 1) is a standard female luer-lockfitting, the luer-lock fitting 220 (FIG. 14) of the adaptor body 22d isrotated with the distal end 26d inserted into the catheter hub 30 tointerlock the corresponding fittings 222, 30 in the known manner. Thecatheter adaptor 22d is then used with the anchoring system in a likemanner to that described above.

Although this invention has been described in terms of certain preferredembodiments, other embodiments apparent to those of ordinary skill inthe art are also within the scope of this invention. Accordingly, thescope of the invention is intended to be defined only by the claimswhich follow.

What is claimed is:
 1. An anchoring system for use with a medicalarticle adapted to be secured to the skin of a patient, said medicalarticle including an elongated tubular body and a radially extendingmember which projects from the tubular body, said anchoring systemcomprising:a retainer including first and second channel portions whichextend about a longitudinal axis, each channel portion generally havinga truncated circular cross-sectional shape with an opening along saidlongitudinal axis, each channel sized to surround at least a portion ofthe tubular body of the medical article through an arc of greater than180° about said longitudinal axis, and at least one lateral slot whichextends generally perpendicular to said longitudinal axis and liesbetween said first and second channel portions, said slot having alongitudinal length so dimensioned to substantially equal the thicknessof the radially extending member of said medical article and less thanthe combined longitudinal lengths of said first and second channels toprovide lateral stability of the medical article with the radiallyextending member positioned within said lateral slot; and a flexibleanchor pad having an adhesive bottom surface and a top surface on whichsaid retainer is mounted, said retainer being positioned on said topsurface in a position exposing the openings to said channel portions. 2.An anchoring system as in claim 1, wherein the first and second channelportions have substantially identical cross-sectional shapes.
 3. Ananchoring system as in claim 1 additionally comprising a tube clipsupported by the anchor pad for securing a tubular portion of a fluidsupply tube connected to the medical article.
 4. An anchoring systemcomprising a medical article having an inner lumen generally along alongitudinal axis of the medical article and a tubular body with aradially extending member projecting from the tubular body, a retainerhaving a longitudinal channel configured to receive in a snap-fit mannerthe tubular body of the medical article, said retainer additionallycomprising at least one lateral slot sized to receive and to capturesaid radially extending member with said medical article positionedwithin said channel of said retainer such that a longitudinal axis ofsaid channel and the longitudinal axis of said medical article aresubstantially parallel, and a flexible anchor pad comprising an adhesivebottom surface which is adapted to attach to a patient's skin, saidanchor pad supporting said retainer.
 5. An anchoring system as in claim4, wherein the lateral slot separates said longitudinal channel intofirst and second channel portions, and the first channel portion issized to receive a proximal portion of the tubular body of the medicalarticle and the second channel portion is sized to receive a distalportion of the tubular body.
 6. A medical device adaptor having agenerally tubular body defined between proximal and distal ends, thedistal end being configured to engage a proximal end of a medical deviceand the proximal end of the adaptor communicating with a fluid tube, aluer-lock connector positioned on the tubular body near the distal endand surrounding the tubular body on at least a plurality of sides of thetubular body, said luer-lock connector being adapted to cooperate with acorresponding luer-lock connector of the proximal end of the medicaldevice and being moveable relative to the tubular body, and a radiallyextending member projecting from an exterior surface of the tubular bodyat a point located between the luer-lock connector and the proximal end,said radially extending member circumscribing the tubular body.
 7. Acatheter adaptor as in claim 6, wherein the radially extending member isan annular collar.
 8. A catheter adaptor as in claim 6, wherein aninterconnection between the luer-lock connector and the tubular bodyprovides for rotational movement between the luer-lock connector and thetubular body.
 9. A catheter adaptor as in claim 8, wherein the luer-lockconnector is secured onto the adaptor between a distal stop, which islocated near the distal end of the tubular body, and the radiallyextending member.
 10. An anchoring system as in claim 1, wherein saidlateral slot is sized to receive the radially extending member of saidmedical article in a snap-fit manner.
 11. A retainer for use with amedical article adapted to be secured to a patient, the medical articlehaving a tubular body with a radially extending member and a distal endcoupled to a proximal end of a medical article, said retainer comprisinga longitudinal channel configured to receive the tubular body of themedical article and a plurality of lateral slots, each lateral slotbeing so dimensioned to receive the radially extending member of themedical article to prevent the medical article from moving in alongitudinal direction, said lateral slots being arranged next to eachother along the longitudinal axis so as to provide multiple positions inthe longitudinal direction in which to insert said radially extendingmember.
 12. A retainer as in claim 11, wherein the lateral slotsseparate the longitudinal channel into a plurality of channel portions.13. A retainer as in claim 12, wherein each channel portion has asubstantially identical cross-sectional shape.
 14. A retainer as inclaim 11, wherein said channel is configured to receive the tubular bodyof the medical article in a snap-fit manner.
 15. An anchoring system asin claim 11, wherein at least one of the lateral slots is sized toreceive the radially extending member in a snap-fit manner.
 16. Ananchoring system as in claim 11, wherein each lateral slot is sized toreceive the radially extending member of the medical article.
 17. Theanchoring system of claim 1, wherein said lateral slot includes acurvilinear lower surface extending below said first and second channelportions to receive said radially extending member of said medicalarticle.
 18. The anchoring system of claim 17, wherein a side of saidlateral slot lies at an elevated level relative to a lowermost point ofthe slot to act as a fulcrum providing leverage when said radiallyextending member is rotated within said lateral slot.
 19. The anchoringsystem of claim 1, wherein said first channel portion is sized toreceive a proximal tubular portion of the elongated tubular body of themedical article and the second channel portion is sized to receive adistal tubular portion of the elongated tubular body of the medicalarticle.
 20. The anchoring system of claim 1, wherein said first channelportion is defined by a pair of opposing walls, each wall having afinger platform extending laterally from the wall distal to saidchannel.
 21. The anchoring system of claim 1, wherein said first channelhas a longitudinal length greater than the longitudinal length of saidsecond channel.
 22. A medical device as in claim 6, wherein saidluer-lock connector has a generally tubular shape which surrounds atleast a portion of the tubular body.